510(k) Report

Devices descending from K910022

57 later devices reach MMG/O'neil Urinary Catheterization System Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973546Kendall Fast-Cath Pre Lubricated Urethral CatheterKendall Healthcare Products Co. Div.Of Tyco Health19970—
+1K973070Conveen Easicath SetColoplast Corp.199755—
+2K242049SureCath SetColoplast Corp.20240—
+2K062444HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitOasis Medikal Urunler Kimya Sanayi VE Tic A.S.20075—
+2K023254SpeedicathColoplast Corp.200353—
+3K223756SimPro™ Now, GentleCath™ HydrophilicDentsply Sirona20230—
+3K212567PVC Hydrophilic Urethral CatheterChengdu Daxan Innovative Medical Tech. Co., Ltd.20220—
+3K192468Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use…Hangzhou Bever Medical Devices Co., Ltd.201911
+3K180258SpeediCath StandardColoplast20181—
+3K161672SpeediCath Flex CoudeColoplast Corp.201610—
+3K133615Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20142—
+3K121458Speedicath Compact Set (12/18 FR)Coloplast A/S20123—
+3K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc.200915—
+3K072808Speedicath CompactColoplast Corp.200712—
+4K251178Ready to use Nelaton CatheterJamjoom Fullcare Corporation20260—
+4K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…Well Lead Medical Co., Ltd.20250—
+4K220722PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20230—
+4K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812…Coloplast20222—
+4K200820SpeediCath Compact SetColoplast20200—
+4K180070SpeediCath Flex Coude ProColoplast20189—
+4K151772Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc.20162—
+4K150935SpeediCath Compact EveColoplast A/S20150—
+4K143182Speedicath Compact MaleColoplast A/S20151—
+4K142563Well Lead PVC Urethral CatheterWell Lead Medical Co., Ltd.20140—
+4K141642Vapro Intermittent CatheterHollister Incorporated201413—
+4K122785Hydrosil; Magic; Personal CatheterRochester Medical Corp.201323
+4K121457Speedicath Compact Set (12 FR)Coloplast Corp.20124—
+4K110862Vapro Plus Intermittent CatheterHollister Incorporated201114—
+5K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)Coloplast20240—
+5K210250SpeedCath Compact MaleColoplast20220—
+5K192904SpeediCath Compact SetColoplast20200—
+5K190620SpeediCath Flex Coude ProColoplast20198—
+5K180801Actreen Hi-Lite Cath, Actreen Hi-Lite SetB.Braun Medical, Inc.20181—
+5K180824VaPro 2 Intermittent CatheterHollister Incorporated20186—
+5K163179Onli Intermittent CatheterHollister Incorporated20173—
+5K152268VAPRO PLUS POCKET Intermittent CatheterHollister Incorporated20150—
+5K150345Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.201512
+5K143594VaPro PocketHollister Incorporated20150—
+6K230165Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10…Coloplast20234—
+6K220667Sleeved ICHollister Incorporated20223—
+6K222059SpeediCath Flex SetColoplast20220—
+6K211436Intermittent Catheter (Not Finalized)Hollister Incorporated202201
+6K200142SpeediCath SoftColoplast20201—
+6K192577Actreen Hi-Lite Intermittent Urinary CathetersB.Braun Medical, Inc.20200—
+6K191633Infyna ChicHollister Incorporated20191—
+6K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated20181—
+6K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.201702
+7K262045Luja SoftColoplast A.S.20260—
+7K241210Luja CoudeColoplast Corp.20242—
+7K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…Hollister Incorporated20242—
+7K233101Luja Coude (20108 Male CH18 - large packaging)Coloplast Corp.20230—
+7K213575Female IC (Not Finalized)Hollister Incorporated20220—
+7K193148VaPro Plus Pocket, VaPro PlusHollister Incorporated20190—
+8K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated20260—
+8K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…Hollister Incorporated20250—
+8K251116Luja CoudéColoplast Corp.20250—
+8K250270Luja SetColoplast Corp.20250—